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The Kamuzu University of Health Sciences Research and Ethics Committee Private Bag 360, Chichiri Progress Report 1. Title of Study 2. KUREC PROTCOL # 3. KUREC Approval Date D D M M Y Y Y Y 4. KUREC Expiration Date D D M M Y Y Y Y 5. Anticipated End Date D D M M Y Y Y Y 6. Principal Investigator 7. Co-Investigator(s) 3 Progress Report version 1.0, 12 Feb 2026
8. Student Investigator(s) 9. Host Department 10. Phone No Email 11. Name of sponsor1 12. Name of funder2 13. Amount of total funding by funder/sponsor (please indicate the currency) 14. Amount of KUHeS overhead fees KUHeS (10%) in the original approved budget (please indicate the currency. Calculate this based on 13) 15. Amount of overhead fees paid to KUHeS (10%) (please indicate the currency and attach the proof of payment) 16. Amount of KUHeS overhead fees outstanding (if any) (please indicate the currency) 17. If KUHeS overhead fees are outstanding, provide an explanation why the fee is outstanding in the space below; 1 A Spo nsor is either an individual, organization or other legal entity which takes responsibility for initiating, managing and/or financin g a study. 2 A funder is an institution, organization or company that simply provides funding, but does not take up the responsibility of initia ting or managing the study. 4
EXECUTIVE SUMMARY OF THE PROJECT In the space below, provide a brief summary of the progress and results obtained to date (Please explain any changes made or are being planned for approval as indicated in C4). A. Project Status: (Since last approval, check one category only.) 1. Enrollment Has Not Begun* ☐ 2. Actively Enrolling Participants* ☐ 3. Enrollment Completed, Contact with Participants Ongoing ☐ 4. Contact with Participants Completed, Analyzing Identifiable Data Analysis Only ☐ 5. Analyzing Identifiable Data (Samples or Data) Only ☐ 6. Analyzing Unidentifiable Data; Data Do Not Contain Identifiers or Linkage to the Data if this is a Program Project, check here ☐ 7. Complete Section E., sign the Progress Report and attached ☐ 5
completed List of Associated Projects ☐ *If enrollment has not begun or you are actively enrolling participants, attach a copy of the consent document used or to be used. B. Number of Participants enrolled, Records Reviewed or Samples Analyzed (if applicable): What is the total sample size? 1. Since last renewal: # of males # of females # of adults # of children 2. Since original approval: # of males # of females # of adults # of children C. (Answer Questions 1 through 7 based on information since last review. Attach a memo explaining “Yes” answers to questions 1 through 6.) Yes No N/A 1. Have any participants withdrawn voluntarily or been withdrawn from the study? ☐ ☐ ☐ 6
2. Have any unexpected side effects, complications, or findings been noted that have not been reported to the Committee? ☐ ☐ ☐ Yes No N/A 3. Have there been any changes to the protocol (participant population, recruitment, study procedures, sample size or consent process) that have not been reviewed and approved by the Committee? ☐ ☐ ☐ 4. Have there been any significant new findings which may relate to the participants’ willingness to continue participation in the study? ☐ ☐ ☐ 5. Has any new information appeared in the literature or been discovered from the study results that would affect the risk- benefit assessment of the project? ☐ ☐ ☐ 6. Has a Data Safety and Monitoring Board been established for this project? If yes, provide a status report from the DSMB. ☐ ☐ ☐ 7. Do any of the participating faculty (or their immediate family, staff or students) have a financial interest (royalty, equity or consulting) in the sponsor and/or products used in this project? ☐ ☐ ☐ Has this been reported to the KUREC previously? ☐ ☐ D. As Investigators indicate your assessment of the progress of this study As expected ☐ Not as expected ☐ (Please explain) Above expectation ☐ 7
E. Funding Status: (select one) Awarded ☐ Pending ☐ Project not funded ☐ If pending or not funded, please explain: D D M M Y Y YY Name and Signature of Principal Investigator Date ***SEE BELOW FOR INVESTIGATOR RESPONSIBILITIES*** Investigator is Responsible for: Making sure that changes, amendments, or addenda made to the protocol or the informed consent process must be submitted to KUREC for review and approval prior to initiating the change. This includes changes in investigator(s), sample size, population, research site, subject compensation, etc. Vulnerable groups shall not to be included in the study unless the study is approved by KUREC The KUREC protocol number shall be cited in all correspondence. Adverse events should be reported promptly to KUREC. Significant new information that may affect the risk: benefit ratio must be submitted promptly to KUREC. Only consent/assent documents with a valid approval date shall be presented to the participants. Signed consent forms for all participants enrolled in the study must be retained on file. All active research projects must be reviewed and re-approved by the KUREC prior to the project’s expiration date. The Principal Investigator is responsible for submitting progress reports by the project’s current submission date. 8
The Principal Investigator is responsible for keeping the Co-Investigator(s) and Student Investigator(s) informed of the status of the project. UPLOADTHIS FORM AND SUPPORTING DOCUMENT(S) IN REIMS KUREC USE ONLY: Project Re-approved for Period to _ Chair/Co Chair KUREC Date and Stamp 9
